Senators Charles Grassley and Herb Kohl, co-authors and co-sponsors of the Sunshine Act, have issued a statement in response to the announcement made by the Centers for Medicare and Medicaid Services.  Last week, CMS posted a notice that it will not require data collection by applicable manufacturers and applicable group purchasing organizations (GPOs) pursuant to the Sunshine Act before January 1, 2013.

The Sunshine Act, or the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act, requires certain drug, device, biological product, and medical supply manufacturers to disclose annually information regarding payments and other transfers of value made to physicians and teaching hospitals. An additional provision requires manufacturers and GPOs to disclose all ownership or investment interests held by physicians or members of their family.

In December 2011, CMS issued a notice of proposed rulemaking announcing the publication of draft regulations to implement the Sunshine Act, which statutorily requires manufacturers and GPOs to begin collecting data starting January 1, 2012.  The proposed regulations suggested that this date may be postponed to 90 days after the final regulations are published. The final regulations have not been published to date.

Last week, CMS indicated on its official blog that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013. In its blog post, CMS states that it intends to release the final rule implementing the Sunshine Act later this year (2012), which will give CMS additional time to “address operational and implementation issues in a thoughtful manner,” and “ensure the accuracy of the data that is collected.”  

Shortly thereafter, Senators Grassley and Kohl issued statements in response to the delay. Senator Grassley noted his disappointment that CMS will not collect data at all in 2012, and his dissatisfaction that the process of implementing the Sunshine Act has exceeded the statutory deadline. Senator Grassley indicated that “consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later,” and expressed that it is “important that CMS get this right in every way, including the usefulness and accuracy of the information.” Senator Kohl also noted his disappointment with the delay, but looks forward to “working with CMS to finalize the rules so that data collection can begin in January 2013.”

To view the Senators’ statement, please click on the following link:  

http://bit.ly/J7HTiR

To view CMS’s blog regarding implementation of the Sunshine Act, please click on the following link:

http://bit.ly/IyhB8n